Engineer-PRQN 755

Loxo; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Loxo is seeking an Engineering professional to support process characterization, optimization, and troubleshooting in manufacturing and pilot plant environments. The role focuses on applying fundamental engineering principles to system modifications and capital projects.

The successful candidate will collaborate with multiple teams, support regulatory compliance, and contribute to cost estimates and schedule management in a dynamic, regulated setting.

Qualifications

• Bachelor’s degree in Engineering with at least 2 years of engineering experience.
• Experience working in a highly regulated pharmaceutical/biotechnology environment is preferred.
• Familiarity with validation processes and documentation practices.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Support operations and engineering initiatives within pharma/biotech settings.
• Collaborate with cross-functional teams to meet schedules and budgets.
• Assist in capital projects, cost estimates, and vendor coordination.
• Contribute to validation activities and regulatory compliance efforts.

Skills

cGMP procedures

Validation protocol writing

Documentation in regulated environment

Vendor coordination

Problem solving

Analytical thinking

Data interpretation

Technical report writing

Time management

Adaptability

Education

Bachelor’s degree in Engineering

Tools

Maximo

Purchase Orders (POs)

Job description

Work Schedule: Onsite – Administrative Shift

Schedule Flexibility: Must be available to work different shifts and/or weekends as business needs require

Positions Available: 1

Contract Duration: 6 months

This opportunity is available only to direct individual candidates. Third-party contractors, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.

Position Summary

Under general supervision, the Engineer will support process characterization, optimization strategies, and troubleshooting of operational issues within manufacturing, operations, pilot plant, and/or capital project environments.

The role applies fundamental engineering principles to the design and implementation of system modifications, experiments, and capital projects. The Engineer will also organize, analyze, and present results related to operational issues and engineering projects of limited to moderate scope and complexity.

Key Responsibilities

General Engineering Functions

Provide solutions to a variety of technical problems of moderate scope and complexity.

Evaluate, select, and apply standard engineering techniques and procedures under general supervision.

Investigate assignments with clear and specific objectives involving a limited number of variables.

Initiate and complete routine technical engineering tasks.

Apply engineering principles to support troubleshooting, process optimization, and operational improvements.

Analyze and interpret technical data and communicate findings and recommendations.

Operations Engineering

Serve as a technical resource for equipment and systems, supporting operational troubleshooting and issue resolution.

Become actively involved in daily operations when necessary to meet schedules or resolve complex technical problems.

Audit the operational performance and regulatory compliance of equipment and systems of significant complexity.

Collaborate with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for system modifications.

Support engineering activities related to pharmaceutical and biotechnology production processes, facilities, and equipment.

Provide technical support for operational issues and engineering initiatives.

Work under the direction of project managers to support design, engineering, and construction projects while maintaining schedule and budget requirements.

Collaborate with consultants, architects, and engineering firms in the development of standard design documents.

Obtain and evaluate vendor quotations for equipment modifications or installations.

Prepare basic project cost estimates and schedules.

Support capital projects and system modifications from an engineering perspective.

Coordinate with vendors and other project stakeholders as required.

Additional Responsibilities

Manage multiple tasks, projects, and priorities simultaneously.

Support engineering activities in a highly regulated pharmaceutical/biotechnology environment.

Perform other related functions as assigned.

Required Education & Experience

Bachelor’s degree in Engineering with at least 2 years of Engineering experience.

Preferred Qualifications

Working knowledge of pharmaceutical and/or biotechnology processes.

Familiarity with validation processes.

Experience with documentation in a highly regulated environment.

Ability to operate specialized laboratory equipment and computers, as appropriate.

Ability to interpret and apply GLP and GMP requirements.

Ability to apply engineering principles and scientific knowledge to production environments.

Ability to develop solutions to routine technical problems of limited scope.

Strong problem-solving and applied engineering skills.

Basic technical report-writing skills.

Understanding of validation protocol execution requirements.

Basic technical presentation skills.

Strong personal organization and time-management skills.

Familiarity with validation protocol writing.

Ability to adapt to and manage change.

Technical knowledge related to equipment and systems.

Analytical problem-solving abilities.

What Would Make a Candidate Stand Out?

Candidates with the following experience or capabilities will be particularly valuable:

Working knowledge and hands-on experience with cGMP procedures and engineering practices within pharmaceutical/biotechnology production processes, facilities, and equipment.

Experience using Maximo.

Experience creating and/or submitting Purchase Orders (POs).

Experience working with, coordinating, and escorting vendors.

Demonstrated ability to manage multiple tasks, projects, and priorities simultaneously.

Flexibility to support 24/7 operations, including occasional after-hours engineering coverage.

Ideal Candidate Profile

The ideal candidate will be an engineering professional who can work effectively in a regulated pharmaceutical or biotechnology environment, troubleshoot equipment and operational issues, and collaborate with cross-functional teams. Strong organizational skills, analytical problem-solving, and the ability to manage multiple priorities are important for success in this role.

Schedule flexibility is also important, as the position may require support outside of the regular administrative schedule based on operational needs.